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| Name | Class |
|---|---|
| Doris Duke Charitable Foundation | OTHER |
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The purpose of this interventional sham-controlled pilot study is to study the effects of using portable air cleaners (PACs) in outpatient adults with prediabetes. The primary aims are to determine the effect PAC's have on glycemic variability and the concentrations of circulating biomarkers of inflammation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Portable Air Cleaner (PAC) Filtration | Experimental | High Efficiency Particulate Air (HEPA) filter will be left intact in the PAC for 4 weeks. |
|
| Sham Portable Air Cleaner (PAC) Filtration | Sham Comparator | High Efficiency Particulate Air (HEPA) filter will be removed from the PAC for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PAC with HEPA filter intact | Device | A commercially available PAC with a true HEPA filter will be used. Unit will be placed in the bedroom and used continuously (24 hours/day) for a total of 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in A Continuous Glucose Monitor (CGM) Coefficient of Variation (CV) | A CGM will be placed at baseline to continuously measure glucose, which will then be used to assess glycemic variability at the end of 4 weeks post-intervention. This outcome will be measured using the following equation: (([post-intervention]-[pre-intervention]))/([pre-intervention])*100% | Baseline, Week 4 |
| Percent Change of C-reactive Protein (CRP) Biomarkers | This outcome will be measured using the following equation: (([post-intervention]-[pre-intervention]))/([pre-intervention])*100% | Baseline, Week 4 |
| Percent Change in Concentration of Interleukin-6 (IL-6) Biomarkers | This outcome will be measured using the following equation: (([post-intervention]-[pre-intervention]))/([pre-intervention])*100% | Baseline, Week 4 |
| Percent Change in Concentration of Tumor Necrosis Factor-alpha (TNFα) Biomarkers | This outcome will be measured using the following equation: (([post-intervention]-[pre-intervention]))/([pre-intervention])*100% | Baseline, Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Newman | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Medical Center | New York | New York | 10016 | United States |
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Sharine.Wittkopp@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will be provided access upon reasonable request. Requests should be directed to Sharine.Wittkopp@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| PAC with HEPA filter removed | Device | Uses the same model as the experimental PAC that is identical in appearance and sound with the HEPA filter removed . Unit will be placed in the bedroom and used continuously (24 hours/day) for a total of 4 weeks. |
|
| D004700 | Endocrine System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |